A Safety and Efficacy Study of Symbicort Turbuhaler Compared With Standard Chronic Obstructive Pulmonary Disease (COPD) Treatment in Japan

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Drug: any available COPD treatment; investigator to decide; Drug: Symbicort Turbuhaler (Budesonide/formoterol)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01070784

D589DC00008

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of Symbicort Turbuhaler compared to standard COPD treatment during one year in Japanese patients with COPD.

Enrollment: 328 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A current clinical diagnosis of COPD according to the guidelines (GOLD, JPS)
• Documented COPD symptoms for more than 2 years
• Pre-bronchodilator FEV1≦50% of predicted normal value, and post-bronchodilator FEV1/FVC<70%

Exclusion criteria

• History and/or current clinical diagnosis of asthma and atopic diseases such as allergic rhinitis
• Subjects with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator
• COPD exacerbation during the run-in period or within 4 weeks prior to registration, requiring hospitalization and/or treatment with systemic steroids.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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328 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Symbicort Turbuhaler (Budesonide/formoterol)

2

Active Comparator group

Treatment:

Drug: Drug: any available COPD treatment; investigator to decide